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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00960310
Other study ID # 60111
Secondary ID
Status Completed
Phase Phase 1
First received August 13, 2009
Last updated March 27, 2017
Start date June 2006
Est. completion date June 2006

Study information

Verified date August 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

- Positive test results for HIV or hepatitis B or C.

- Treatment for drug or alcohol dependence.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sandoz

Outcome

Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 11 days
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